Over the last two decades, protection systems for protecting a health operator's head and face based on a helmet to be worn during surgery have become of widespread use. Traditionally, such systems are mainly formed just by a helmet, a cap or a protection gown covering the helmet, by a lens i.e., a transparent splash guard visor constrained to the cap or gown, by a drive unit and a related power-supplying battery. As mentioned, the system is worn by the health operator during surgery.
These systems are especially used in orthopedic surgery, with specific reference to surgery for implanting knee and hip prostheses, in which drills provided with reamers and saws are used. In that sense, helmets have proven to be superior protection to that afforded by masks and common face protection shields, as a helmet covers the entire head of the health operator, creating a sterile barrier between the health operator and the patient. Such a barrier protects the operator from the considerable amount of possibly contaminated blood spurts emitted in the course of surgery.
Moreover, the helmet generally comprises a fan for air circulation inside the environment accommodating the surgeon's head. Such air circulation opposes perspiration and contributes to keeping the air inside the facial chamber cool, thereby increasing the operator's comfort level.
In addition, air circulation also offers a valid protection against the so-called “aerosol effect” of virus-contaminated particles. Potential infection risks for the surgeon associated with the aerosol effect and benefits from the use of surgical helmets are amply demonstrated in literature (see, e.g.: Jonathan A. Eandi et al., “Use of a surgical helmet system to minimize splash injury during percutaneous renal surgery in high-risk patients,” Journal of Endourology, Vol. 22, No. 12, December 2008).
Moreover, the above-mentioned systems offer protection for the patient as well, with respect to contaminations coming from the surgeon and other health operators, e.g., hair, dandruff and saliva droplets, and therefore the possibility of wound infection. Infection rates described in literature are between 0.38% and 2% for THA (Total Hip Arthroplasty) and between 0.77% and 4% for TKA (Total Knee Arthroplasty), with data increasing in the course of revision surgery.
Therefore, for all purposes the above-mentioned protection system based on a surgical helmet may be deemed to be both a medical device, owing to the protection offered to the patient, and an individual protection device for the health operator.
Main Drawbacks of Known Art
The above-described known protection systems suffer from some relevant drawbacks.
First of all, a mere ventilation of the head-accommodating environment is useless to prevent carbon dioxide accumulation inside the same environment and does not effectively oppose the lens fogging phenomenon, related above all to the health operator's breathing. In connection with this latter aspect, the Inventors observed that only in the first stages of surgery, such fogging is reduced by means of fan-produced air circulation.
However, as time passes—a hip or knee prosthesis surgery can last up to several hours—besides fogging, the above-mentioned CO2 accumulation occurs, which may cause queasiness. In fact, the cap or robe associated with the helmet may “seal” the environment at the neck level, allowing no adequate CO2 evacuation below the helmet.
To this end, it should be noted that for the manufacturing of the robe or cap, the evolution of the field leads to the use of repellent materials, in particular polypropylene ones, preventing perspiration.
Moreover, the known systems have remarkable weights and encumbrances even at the level of the sole helmet (which is then to be associated to lens, motor and battery), penalizing the health operator's comfort at the head level and accordingly limiting his/her body motions.
Furthermore, in the known systems the cap-lens unit is kept in position on the helmet by Velcro® arranged on the lens and on the stationary structure of the helmet. This complicates the undressing modes of the health operator, who should separate the coupled strips by tearing them off, and may result in inaccuracy in the position of the entire protection system, and specifically of the lens in the dressing stage, since the strips may adhere accidentally according to a coupling configuration different from the desired one.